Dementia Clinical Trial
— TREAOfficial title:
Treatment of Agitation in the Nursing Home
The purpose of this study is to examine the efficacy of non-pharmacological ways to treat agitated behaviors in nursing home residents with dementia. The hypothesis is that non-pharmacological interventions will be more effective than placebo in decreasing such behaviors.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Age 60 or older - Diagnosis of dementia derived from the resident's medical chart at the facility or from an attending physician, as based on DSM-IV criteria and the Report of the NINCDS-ADRDA - Resident of the facility for at least three weeks so that nursing staff members know the resident well enough to accurately assess him or her - Identified by nursing staff to exhibit either verbal agitation or physical non-aggressive agitation at least several times a day Exclusion Criteria: - Lifelong diagnosis of schizophrenia - Bipolar disorder diagnosed prior to onset of dementia - Diagnosis of premorbid mental retardation - Judged by direct-care nursing staff to have a life expectancy of less than 3 months - Expected to leave the nursing home (either to enter the hospital or to go home) within the next 4 months - Agitation manifested less than 6 times a day |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Research Institute on Aging | Rockville | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute on Aging (NIA) |
United States,
Cohen-Mansfield J, Libin A, Marx MS. Nonpharmacological treatment of agitation: a controlled trial of systematic individualized intervention. J Gerontol A Biol Sci Med Sci. 2007 Aug;62(8):908-16. — View Citation
Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84. — View Citation
Cohen-Mansfield J. Agitated behavior in persons with dementia: the relationship between type of behavior, its frequency, and its disruptiveness. J Psychiatr Res. 2008 Nov;43(1):64-9. doi: 10.1016/j.jpsychires.2008.02.003. Epub 2008 Apr 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Agitation Behavior Mapping Instrument (ABMI) | 10 days of intervention vs. 10 days of baseline | No | |
Secondary | affect/mood measured by Lawton's behavior stream assessment | 10 days of intervention vs. 10 days of baseline | No |
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